Nchi: Malesia
Lugha: Kiingereza
Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BENZYDAMINE HYDROCHLORIDE
HEALOL PHARMACEUTICALS SDN. BHD.
BENZYDAMINE HYDROCHLORIDE
100ml x 10 BOTTLE
ICPA Health Products Limited,
COOLORA _Consumer Medication Information Leaflet (RiMUP)_ (Benzydamine Mouthwash BP 0.15%w/v) 1 WHAT IS IN THIS LEAFLET 1. What COOLORA is used for 2. How COOLORA works 3. Before you use COOLORA 4. How to use COOLORA 5. While you are using it 6. Side effects 7. Storage and Disposal of COOLORA 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT IS COOLORA USED FOR Benzydamine hydrochloride in COOLORA is used to relieve inflammation and pain in the throat. HOW COOLORA WORKS COOLORA works by reducing the pain, redness and swelling of painful mouth and throat conditions. BEFORE YOU USE COOLORA _-When you must not use it _ Do not use this medicine if you have an allergy to: • any medicine containing Benzydamine hydrochloride • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. Pregnancy and breastfeeding If you are pregnant, trying to become pregnant or breastfeeding, ask your pharmacist or doctor for advice before using COOLORA. Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If you are not sure whether you should start using this medicine, talk to your pharmacist or doctor. _-Before you start to use it _ Tell your pharmacist if you have allergies to any other medicines, foods, preservatives or dyes. Tell your doctor or pharmacist if you have any of the following medical conditions: • Liver problems • Kidney problems If you have not told your pharmacist or doctor about any of the above, tell him/her before you start using COOLORA. _-Taking other medicines _ Tell your pharmacist or doctor if you are taking any other medicines, including any that you get without a prescription or that are herbal from your pharmacy, supermarket or health food shop. Soma hati kamili
For the use of a Registered Medical Practitioner or Hospital or a Laboratory. COOLORA (BENZYDAMINE MOUTHWASH BP 0.15% W/V) ACTIVE INGREDIENT: Benzydamine Hydrochloride BP (Each mL contains 1.5 mg of Benzydamine hydrochloride) Sodium Benzoate BP 0.20%w/v as preservative EXCIPIENT: Glycerin BP, Propylene Glycol BP, PEG Hydrogenated Castor Oil (Acrysol K 140), Menthol BP, Flavor Booster, Flavor Dill Relish, Sodium Saccharin BP, Brilliant Blue FCF Color, Tartrazine Yellow Color, Purified Water BP. DOSAGE FORM: Liquid for use as mouthwash/ gargle. PRODUCT DESCRIPTION: A Light green coloured clear liquid with characteristic taste and fennel odour. PHARMACODYNAMICS: Pharmacotherapeutic group: Other agents for local oral treatment Benzydamine exerts an anti-inflammatory and analgesic action by stabilizing the cellular membrane and inhibiting prostaglandin synthesis. Mechanism of action: The indazole analogue benzydamine has physicochemical properties and pharmacological activities which differ from those of the aspirin-like NSAIDs. Unlike aspirin-like NSAIDs which are acids or metabolized to acids, benzydamine is a weak base. In further contrast, benzydamine is a weak inhibitor of the prostaglandin synthesis. Only at concentration of 1mM and above benzydamine effectively inhibits cyclooxygenase and lipooxygenase enzyme activity. It mostly exerts its effects through inhibition of the synthesis of pro-inflammatory cytokines including tumor necrosis factor-alpha (TNF-α) and Interleukin-1β (IL-1β) without significantly affecting other pro-inflammatory (IL-6 and 8) or anti-inflammatory cytokines (IL-10, IL-1 receptor antagonist). Further mechanisms of action are hypothesized including the inhibition of the oxidative burst of neutrophils as well as membrane stabilization as demonstrated by the inhibition of granule release from neutrophils and the stabilization of lysosomes. The local anaesthetic activity of the compound has been related to an interaction with cationic channels. Pharmacodynamic effects: Benzydamine specific Soma hati kamili